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NCT05828589 · ClinicalTrials.gov registry record · Phase 1
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
A Phase 1 study of Refractory Chronic Lymphocytic Leukemia and Refractory Non-Hodgkin Lymphoma, sponsored by BeOne Medicines.
- Active
- Registry status
- Phase 1
- Development phase
- 112
- Enrollment target
- 20
- Study locations
NCT05828589: Active Phase 1 study of Refractory Chronic Lymphocytic Leukemia and Refractory Non-Hodgkin Lymphoma, sponsored by BeOne Medicines.
NCT05828589 is a Phase 1 study of Refractory Chronic Lymphocytic Leukemia and Refractory Non-Hodgkin Lymphoma that is active but no longer recruiting, run by BeOne Medicines. The registered enrollment target is 112 participants, above the 55-participant average among 19 other Refractory Chronic Lymphocytic Leukemia trials with a reported enrollment target (104% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05828589, a Phase 1 study of Refractory Chronic Lymphocytic Leukemia and Refractory Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by BeOne Medicines.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 112 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Optimization."
Primary Outcome
Number of participants with dose limiting toxicities, as defined in the study protocol.
Conditions Studied
Interventions
- DRUG BGB-21447
Study Locations (20)
Jiangsu
- The First Peoples Hospital of Changzhou - Changzhou
- Jiangsu Province Hospital - Nanjing
- The First Affiliated Hospital of Soochow University - Suzhou
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
- Mission Cancer and Blood - Waukee
New York
- Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island - Mineola
- Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health - New York
Queensland
- Pindara Private Hospital - Benowa
- Mater Cancer Care Centre - South Brisbane
Hubei
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology - Wuhan
- Yichang Central Peoples Hospitaljiangnan Branch - Yichang
District of Columbia
- Sibley Memorial Hospital Johns Hopkins Medicine - Washington D.C.
Maryland
- Sidney Kimmel Comprehensive Cancer At Johns Hopkins - Baltimore
South Dakota
- Avera Cancer Institute - Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2023-06-20 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
What the registry record for NCT05828589 still lists
NCT05828589 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, above the 55-participant average among 19 other Refractory Chronic Lymphocytic Leukemia trials with a reported enrollment target (104% higher).
The record links to 10 conditions, with Refractory Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which BGB-21447 is the first listed.
NCT05828589 names 20 study sites across 14 states, led by Jiangsu, Iowa, New York.
Frequently Asked Questions
What is clinical trial NCT05828589 about?
NCT05828589 is a clinical study titled "A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies". This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum adminis...
What is the current status of trial NCT05828589?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2023-06-20. Estimated completion is 2026-05.
What conditions does trial NCT05828589 study?
This clinical trial studies the following conditions: Refractory Chronic Lymphocytic Leukemia, Refractory Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Follicular Lymphoma, Refractory Marginal Zone Lymphoma.
What interventions are being tested in trial NCT05828589?
The interventions under investigation include: BGB-21447 (DRUG).
Who is sponsoring clinical trial NCT05828589?
This trial is sponsored by BeOne Medicines, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05828589 being conducted?
This trial has 20 study locations across District of Columbia, Iowa, Maryland, New York, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05828589's enrollment target sits among peer trials
112 4th of 19 higher than 16 of 19 other Refractory Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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